Dilating and support apparatus with disease inhibitors and methods for use

ABSTRACT

A dilating and support apparatus with disease inhibitors and methods for use is disclosed that is particularly useful for repairing and/or serving as a conduit for body passageways that require reinforcement, dilatation, disease prevention or the like. Such apparatuses are utilized to deliver a therapy, that therapy being from a family of devices, drugs, or any of a variety of other elements to a specific location within the body. The instant disclosure provides a system of combining a novel radial deployment and/or drug delivery therapy with existing balloon dilatation therapy into one device. This combination will yield a significant decrease in cost to the healthcare system as well as providing a therapy to the patient with increased safety and efficacy. Further, the instant invention provides a novel and improved platform for synthetic/tissue interface between the device and the body.

CROSS REFERENCE TO RELATED APPLICATION

[0001] The present invention is a continuation of provisional patentapplications Ser. No. 60/083,178 filed on and claiming priority of Apr.27, 1998, Ser. No. 60/095,106 filed on and claiming priority of Aug. 03,1998 and Ser. No. 60/115,548 filed on and claiming priority of Jan. 12,1999, the full disclosures of which is incorporated herein by reference.

[0002] 1. Field of the Invention

[0003] The present invention relates to medical devices and theirmethods of use. More specifically, the present invention relates todevices which are particularly useful for repairing and/or serving as aconduit for body passageways requiring reinforcement, dilatation,disease prevention or the like. Such devices are utilized to deliver atherapy, that therapy being from a family of devices, drugs, or any of avariety of other elements to a specific location within the body.

[0004] The present invention provides a system of combining a noveldeployment and/or drug delivery therapy with existing balloon dilatationtherapy into one device. This combination will yield a significantdecrease in cost to the healthcare system as well as providing a therapyto the patient with increased safety and efficacy. Further, the instantinvention provides a novel and improved platform for synthetic/tissueinterface between the device and the body.

BACKGROUND OF THE INVENTION

[0005] Occlusive vascular disease is a common ailment in peopleresulting in enormous costs to the health care especially with the‘Graying of America’ due to the baby boomers of the 50's. The commonprocedure of dilatation of these occluded vessels of the body has beenstudied for several years and many techniques (devices and methods) havebeen studied and practiced. One of the more common techniques is onereferred to as balloon angioplasty or Percutaneous TransluminalAngioplasty (PTA). PTA is the most common treatment of atheroscleroticplaque deposition. However, this PTA has significant drawbacks; some ofwhich are the cost of the catheter and the potential for the stenoticvessel to ‘recoil’ or narrow back down after the procedure. Hencescaffolds (stents or stent-grafts) have been designed that stay in placeto keep the vessel ‘propped open’ after dilatation. Other significantdesign changes have occurred with PTA such as the use of drugs pre,during and post dilation. Balloons have been designed with permeablemembranes to aid with this delivery. Further, the balloons have beendesigned with imperfections in the surface of the balloon that aid inbreaking up the plaque matrix during dilation (tiny cutters for examplehave been impregnated into the exterior wall of the balloon). Furtherenergy dispersal systems have been employed to deliver energy to thesite pre, during or post therapy (e.g. radiation, electricalstimulation, RF, etc.). Even further, extravagant perfusion systems havebeen developed with the dilatation systems so that blood can flow duringthe therapy. All of these proposed ‘enhancements’ add significantly tothe cost and complexity of the dilation or stent device. The presentinvention allows all of these enhancements to occur with an overallreduction in the manufacturing resources required for the device sinceone device/catheter is required as opposed to two or more. Even moreimportant, is the time efficiencies created during the procedure byobviating the need to exchange the devices/catheters to perform the actswhich may include angioplasty, stent deployment, and drug delivery.Safety to the patient is enhanced, as well, by obviating the timeconsuming exchanges and diminishing the time of the procedure.

[0006] Also, despite the evolution of a variety of mechanical techniquesand adjunctive therapies, approximately 30-45% of patients treated withballoon angioplasty will develop a recurrent stenosis within six months.Stenting of the lesion will decrease the re-stenosis rate to 20-30%,although with additional cost and risks. The cost of treating patientswith re-stenosis which require another revascularization procedure oradditional therapy and has been estimated to cost 2500 lives and $4billion. Re-stenosis is a complex process, which is due to somecombination of suboptimal results, acute mechanical recoil, thrombosisand platelet deposition, smooth muscle proliferation, extracellularmatrix production, and geometric remodeling as well as other reasons notreported here. Because of the improvement in the re-stenosis rate withintraluminal stents, it is likely that stenting prevents the mechanicalevents which contribute to re-stenosis, i.e., suboptimal results, acutemechanical recoil, and geometric remodeling. However, stenting has beenshown to accelerate or incite smooth muscle proliferation, thrombosisand platelet deposition, and matrix production. These events may begrouped together and referred to as neointimal hyperplasia. Exuberantneointimal hyperplasia may lead to stenosis within a stent, referred toas in-stent re-stenosis. Therefore, stents may improve the restenosisrate, but at a significant financial cost, potential risk to thepatient, and a possibility of developing in-stent stenosis. Hence, anovel invention that allows safer, less expensive and more efficaciousdilatation and stent deployment is described in the present invention.

[0007] As stated, stenting is not the cure all. Moreover,pharmacological therapy has not been shown efficacious in significantlyreducing neointimal hyperplasia, for several different reasons. Onereason is related to the systemic intolerances of doses required toachieve local beneficial effects within the arterial wall. A local drugdelivery device which would deliver higher drug concentration to thetarget while avoiding systemic toxicity's or side effects would beadvantageous. In fact there are several patented local drug deliverydevices, including balloon catheters, coated stents, and even needlecatheters. However, most are plagued with the rather uniform problem oflow transfer efficiency, rapid washout/poor retention, and the potentialof additional vessel injury. Most also require insertion of a separateand specialized catheter separate from the angioplasty balloon catheter,which is a time consuming, costly, and potentially a risky maneuver.

[0008] There are many techniques and devices known in the art forremoving blockages, repairing occlusions and otherwise preventing ortreating disease in the passageways of the human body. Further, manyapproaches exist to treat the synthetic/tissue interface that existswhen using medical devices and implants in the body. However, there is acontinuing need for improved devices to meet at least the followingobjectives.

[0009] The first objective is to reduce cost. This is particularlyimportant in recent years where it is clear for safety and sanitaryreasons that these will be single use devices. A device, even though itperforms a function in some improved manner, will not be widely used ifit is considerably more costly than the alternatives available.

[0010] A second objective is to provide a device that is simple to useand in a very real sense simple to understand. This will encourage itsadoption and use by medical personnel. It will also tend to keep costlow.

[0011] The third objective is to provide a device that entails aprocedure with which the medical profession is familiar so that theskills that have been learned from previous experience will continue tohave applicability.

[0012] A fourth objective relates to the effectiveness and thoroughnesswith which the blockage is removed. It is important that a maximumamount of the blockage be removed; recognizing that no device is likelyto provide one hundred percent removal.

[0013] A fifth objective concerns safety; a matter which is often socritical as to trump the other considerations. It is important to avoidtissue trauma. In many circumstances, it is critically important toavoid breaking up a blockage in a fashion that leads to flushingelements of the blockage throughout the body involved.

[0014] There are trade-offs in design considerations to achieve theabove five interrelated objectives. Extreme simplicity and a very simpleprocedure might over compromise safety. Addressing all of theseconsiderations calls for some trade-off between the objectives.

[0015] Accordingly, a major object of this invention is to provide animproved device for treatment or prevention of disease of a bodypassageway, which achieves the objectives of, reduced cost, enhancedsimplicity, a standard procedure, high effectiveness and a high degreeof safety. Most particularly, it is an object of the present inventionto achieve these objectives with an enhanced trade-off value for thecombined objectives.

BRIEF DESCRIPTION

[0016] A novel device description is set forth in the instant inventionthat allows for treatment of fully or partially occluded vessels withinthe body; usually those vessels being blood vessels. In brief, theinstant invention allows multiple therapies to be provided with a singledevice. One embodiment of the instant invention is to provide a singledevice/catheter/guide wire that allows for balloon angioplasty of astenotic lesion in the vasculature and deployment of a device forpropping open the vessel with that same device. This is often referredto as an endoprosthesis, but more frequently referred to as a stent orstent-graft. Usually stenosis of a blood vessel is treated by placing aballoon in the narrowed/stenosed area of the vessel and expanding theballoon, which subsequently expands the narrowed vessel, at leasttemporarily or partly. This balloon expansion is referred to as balloonangioplasty. Unfortunately, too often after balloon angioplasty, thevessel returns to its original ‘narrowed’ condition. This is referred toas recoil, if it occurs acutely. Subacute or late narrowing may besecondary to restenosis, a complex process described more fullyelsewhere in this document. These processes occur in a large percentageof ‘ballooned’ vessels, sometimes upward of fifty percent. Because ofthis limited long-term success, balloon angioplasty is frequently usedin addition to, or in conjunction with, other therapies such asplacement of a stent, stent-graft, or subsequent drug delivery to thearea of stenosis or re-stenosis. The additional therapies will hopefullyprevent the re-closure of the vessel after balloon angioplasty. Thesesubsequent therapies require the addition of new devices after balloonangioplasty. Hence, it is standard procedure to remove the angioplastydevice only to replace it with another device that either delivers thestent or stent-graft, and even another device, which delivers the drugor other therapy. Hence it is the preferred embodiment of the instantinvention to provide a device that can expand the vessel via a balloonangioplasty device, but also provide a system that can simultaneously orsubsequently deliver a therapy such as a stent or stent-graft or deliveragents/drugs without the removal of the original angioplastydevice/catheter.

[0017] Conversely, a novel therapeutic device is described in theinstant invention that can dilate the narrowed vessel without the use ofa balloon and can then deploy a stent or stent-graft with a balloon orwith another novel mechanism on the same device.

[0018] Further, another preferred embodiment of the instant inventionallows for a therapeutic delivery of a drug or other agent to tissue toprevent or treat disease. In particular, during balloon angioplasty,this is accomplished without an additional device being used for thistherapy.

[0019] The instant invention is primarily, though not exclusively,oriented to the use of technology referred to as tubular braid orbraided sleeving. The basic design of tubular braid is well definedlater in the patent under a particular ‘comments’ section entitled TheTubular Braid or Braided Sleeve Element.

[0020] 2. Description of Background Art

[0021] Intraluminal devices or endovascular prostheses are known fortreating stenosis, stricture, aneurysm conditions and the like. Oftenthese devices are implanted or used via LIS (Least Invasive Surgery);whereby a small percutaneous access into the vessel is accomplished(usually remote to the diseased area). Alternatively, they are installedvia an ‘open surgery’ approach. Advantages of the LIS approach (overconventional surgery) are significant from a cost as well as a patientcare and recovery point of view. Balloon catheters have found anincreased use in medical procedures such as percutaneous transluminalangioplasty (PTA), percutaneous transluminal nephrostomy, ureteraldilatation, biliary duct dilatation, percutaneous transluminal renalangioplasty and the like. Intellectual property regarding balloondilatation is extensive and shall not be exhaustively reported here,however, certain patents deemed relative are described. Gruntzig et alin U.S. Pat. No. 4,195,637 and Simpson et al in U.S. Pat. No. 4,323,071are two very well known patents that have been said to initiate theonslaught of intellectual property that is realized with balloonangioplasty. These two patents describe initial intellectual propertyassociated with balloon angioplasty and are often referenced as a basisfor such discussions, however have little relevancy to the inventionsdisclosed herein except for that basis. U.S. Pat. Nos. 4,448,195,4,637,396, 4,608,984 and 4,646,742 describe balloons reinforced withfabric and/or multi-layer construction to increase strength and controlexpansion. Levi U.S. Pat. No. 4,490,421 is a well-discussed patent thatdisclosed the use of PET materials in the fabrication of angioplastyballoons that allow high pressures without rupture. Stents andstent-grafts have in-depth coverage in the intellectual forefront aswell. A predominant stent patent by Palmaz, U.S. Pat. No. 4,776,337discloses a well-known device frequently referred to as a Self-ExpandingStent. Self-Expanding Stents have come of favor recently over balloonexpandable stents for reasons not completely understood by the author,but likely due to the perceived decrease in effort to deploy the stentsince there is only the initial balloon dilatation and then stentdeployment instead of balloon dilatation, and balloon dilation/stentdeployment a second time to implant the stent or stent-graft. However,multiple catheter exchanges must be made to dilate the lesion with theangioplasty catheter, deliver the self expanding stent with anothercatheter or delivery device, and then reinsert the angioplasty ballooncatheter to tack the stent down properly. Further, because stentplacement is still relatively new in medicine, the interventionalist isalways left with the question of long-term reliability (with regard torestenosis) of all stent placements. Intraluminal scaffolding devicessuch as stents are often used in combination with grafts and vice versa.The graft is usually, but not always a an elastic or inelastic materialand often a textile/fabric type material that is used to cover a greaterarea of the scaffolding as well as aid in neo-intimal formation afterplacement. Further, the two (stents and grafts) are often designed intoone device called a stent-graft.

[0022] One embodiment of the present invention allows balloon dilationand stent deployment to be accomplished with one device. In and ofitself, this technique as well as other inventions have tried toaccomplish the same, but have been met with limited success. LeVeen,LeVeen and LeVeen in U.S. Pat. No. 4,404,971 describe a dual ballooncatheter to control bleeding to facilitate surgical closure of the bloodvessel. Taking this multiple balloon concept further, Hegde et al inU.S. Pat. No. 5,725,535 describe a method for using a multiple ballooncatheter that allows balloon dilatation of the stricture and then stentdeployment using the same catheter. However, the resulting multipleballoon device is more than complicated and Hegde et al disclose amethod for a complex and expensive device. Further, using balloons fordilatation and for stent deployment require a significant amount of timefor inflation/filling and subsequent deflation/un-filling of theballoons. The rate of inflation and deflation of the balloons bearsdirectly on the stress induced on the heart during the procedure. InU.S. Pat. No. 5,725,535, Hegde et al describes the multiple balloondevice in detail in the body as well as in the claims. However, inaddition to the inflation and deflation times mentioned above, thedevice described in this patent has the obvious drawbacks of requiring aseparate lumen for each balloon. In addition to increasing the cost ofmanufacture, this requirement requires the overall diameter of thecatheter to be increased. Marin and Marin in U.S. Pat. No. 5,456,694describe an extravagant catheter similar to the Hegde patent wherebymultiple balloons are used to accomplish the same as in the Hegdepatents. Marin and Marin disclose a guiding sheath in cooperation withtheir multiple balloon system that has a variable stiffness that is madeavailable through their design that reportably decreases trauma to thepatient. Marin and Marin recognize the limitations of multiple balloonsin their design and make mention of alternative mechanical linkages todeploy the stents. These linkages are described in Marin's U.S. Pat.Nos. 5,618,300 and 5,443,477. Marin and Marin indeed describe analternative mechanical linkage device for stent deployment in thesesubsequent patents, however again only at the cost of losing costeffectiveness in the manufacture of the catheter as well as thepotential increase in size of the diameters of the catheters andpotential flexibility of the catheter/device. Further, in U.S. Pat. No.4,585,000, Harold Hershenson describes a mechanical linkage type dilatorthat is similar to that of Marin and Marin in that it is complicated formanufacture and difficult for size reduction which is of paramountimportance. Further, all of these mechanical linkages lend themselves toan inflexibility characteristic. Because of the tortuous paths realizedin the vasculature, flexibility of the catheter/device is critical. Itis often the case that narrowing of vessels in the body often occur attortuous curves or bifurcations similar to shallows in a stream orriver.

[0023] Hence in the present invention, described herein, the inventorsdescribe a multiple use device/catheter, that can be made in a low costmanufacturing environment while keeping diameter of the device to aminimum, but keeping safety and efficacy to the patient at a maximum.The present invention utilizes a manufacturing technique known astubular braid or braided sleeving to accomplish either dilatation orstent deployment. The instant invention may be used with a dilationballoon on the device in combination with the tubular braid. When thetubular braid is put into compression, the braid expands radially fordilation and/or stent deployment. Further, the inventors disclose anovel device and method for using a single device for dilatation andstent deployment without the need for balloons at all. Embodiments aredescribed which will provide the capability of balloon dilation anddeployment of an expandable stent or a self-expanding stent.

[0024] Additionally, the inventors disclose the use of tubular braid asa device to deliver drug/agent/therapy to passageways as well.

[0025] The use of tubular braid for use in the tubular vessels of thebody is not new and is described in several issued U.S. patents.Anderson et al in U.S. Pat. No. 4,706,670 describes a unique use oftubular braid in conjunction with balloon angioplasty. In thisdisclosure, Anderson et al describe the use of tubular braid that ismolded into an elastomeric catheter shaft so that upon expansion of thecatheter from within, the shaft only expands and dilates to a fixeddiameter that is predetermined by the inelastic tubular braid filamentswithin the walls of the catheter. When pressure is removed from thedevice the diameter contracts back to its original, ‘undilated’diameter. In U.S. Pat. No. 4,650,466, Ronald Luther describes a tubularbraided device for use in angioplasty where the expanded braid is usedfor removal and trapping of debris during said angioplasty. In U.S. Pat.No. 4,572,186, Gould et al describe a dilation catheter using tubularbraid. Gould describes the objectives of his inventions to replaceangioplasty balloon for providing improved dilating forces, decreasedcosts, and radiopacity and improve upon balloon dilation limitationssuch as the forces realized with balloon catheters are not realizeduntil the balloon is almost filled with filling agent. Hence Goulddescribes a dilatation device using braid that does not necessarily gofrom a very small diameter to a very large diameter that is evidenced bythese objects as well as are realized in his illustrations. Further, andagain, Gould did not invent the use of the tubular braid in conjunctionwith other dilation or deployment. In fact due to the description thatthe author gives in the patent, it is likely that the inventors couldnot determine a design that would transmit significant force to a bloodvessel so as to actually dilate the vessel and the underlying stenotic,atheroma/plaque which tends to be a hard and sinuous material that isnot too receptive to dilatation without constraining his design to smallincremental dilations from said small catheter shaft to only a slightlylarger diameter shaft after deployment. The same Applicant with adifferent Inventor, Richard Hillstead in U.S. Pat. No. 4,921,484describes a Mesh Balloon Catheter device. Hillstead discusses the use ofthe tubular braid for stent deployment, filtering and centeringcharacteristics in the body of his disclosure, but limits his inventionto drainage of the device wherein fluid accumulation occurs in theexpanded tubular braid or with other flushing lumens there-through withregard to using the device for the compression and or removal ofmaterial during an angioplasty. Certainly nowhere does Hillsteadrecognize the advantage of combining the tubular braid with balloonangioplasty, nor it is obvious to anyone normally skilled in the art.Hillstead describes an intricate device for expanding the tubular braid.The mechanism described in the Hillstead patent misses the importance ofdecreased diameter of the catheter, decreased manufacturing costs, theimportance of physical flexibility of the catheter and importantly theinvention of coupling the more than one tubular braid mechanism withanother or with a balloon dilator to decrease the overall cost of thedevices required for dilatation and stent placement or the increase insafety and efficacy that such a design gives to the patient. Wholey etal in U.S. Pat. No. 4,723,549 describes a method and apparatus fordilating blood vessels. Wholey describes a tubular braid being used as afilter or trap to collect emboli that may become dislodged during theintervention. A balloon is used to expand tubular braid that remainsexpanded as a filter or trap during the PTA procedure. Further, in U.S.Pat. No. 5,034,001, Garrison et al discloses an angioplasty device witha temporary stent that may be fabricated from tubular braid. Thistemporary stent in the Garrison et al patent is used to help prevent theproblems that are realized with instantaneous recoil subsequent toangioplasty/balloon dilatation.

[0026] In fact, the present inventors have several patents some of whichhave issued and some of which are pending that use the tubular braidsfor medical devices. In U.S. Pat. No. 5,498, 5,280,273, 5,713,848 andContinuation of these issued patents, Ser. No. 098/005,217, the currentinventor discloses the use of tubular braid as an occluder and as afilter and trap for dislodged emboli and blood particulate. Further, thecurrent inventor in U.S. Pat. No. 5,431,676 uses tubular braid tofacilitate a radially expanding trocar. Even further, the currentinventors in pending U.S. and PCT submissions (U.S. Ser. No. 09/063,735and PCT/US Ser. No. 98/08194) disclose tubular braid in the fabricationof embolic containment devices as well as tubular braid use for abifurcated stent. Further yet, the current inventors use tubular braidin the design and disclosure of devices and methods for entrapping,occlusion, flow direction, tensioning and/or anchoring devices in U.S.Ser. Nos. 09/248,08809/248,083 and PCT/IUS Nos. 99/02856 and 99/02853.

[0027] However, none of the references mentioned above disclose a newdevice that can be used as a combination dilatation device and stentdeployment device that allows increase patient safety and efficacy withan overall reduction in the manufacturing costs and complexity of thecombined device or its use by the physician as does the novel inventiondisclosed herein.

[0028] Turning now to another embodiment of the instant invention, thatof utilizing the tubular braid in conjunction with an angioplastyballoon (or other dilatation means) for concurrent balloon angioplastyand drug delivery/therapy. This instant invention uses a tubular braidor other similar material that may have an absorbent nature such asDacron, cotton etc. The absorbent material is placed over a balloon orother dilation device. Prior to placing the balloon into the diseasedlesion, the absorbable material is allowed to absorb a therapeutic agentinto the individual filaments or in between the filaments and the outerwall of the balloon or other dilatation device. When the dilatationdevice is placed into the constricted area/lesion of the vessel and thedilated, the drug or other agent is then driven into the vessel wall atthe site of the lesion, where it is needed most. Further, the coveringmaterial, such as the tubular braid, will act as a means for penetratingthe lesion and potentially breaking up the plaque matrix that existsthere. Certainly, the drug/agent/therapy will at very least be deliveredinto the lesion/diseased site, again where it is need most.

[0029] U.S. Pat. No. 4,994,033 by Shockey describes an intravasculardrug delivery dilatation catheter that disclosed a plurality of minuteholes within a set of balloons for subsequent delivery of a drug duringangioplasty. However, Shockey et al describes a device that is costlyand complicated to manufacture. Wolinsky et al in U.S. Pat. No.5,087,244 describes a method and catheter with minute holes(approximately 25 microns) through the balloon wall as well forconcurrent drug delivery during angioplasty. The repeatability of thesized 25 micron holes in the balloon coupled with the potentialrestrictions of the drug used for perfusion through these holes lenditself to these disadvantages. In U.S. Pat. No. 5,279,565, Klein et aldescribes a device and method for infusing an agent to the treatmentsite as well. Klein et al discloses a rather complex device that wouldlend itself to costly manufacture if it would be put to practice. FahradKhosravi in U.S. Pat. No. 5,415,637 discloses a temporary stentingdevice with drug delivery capabilities. In his disclosure, Khosravidescribes a device that will deliver drugs while propping open anarrowed vessel using an elaborate set of hypotubes with holes drilledin them. As compared with the instant invention, this device willgreatly exceed manufacturing costs as well as decrease flexibility ofthe catheter, which described earlier, is of paramount importance.

[0030] The use of drug/agent/therapy devices to be used concurrentlywith angioplasty has been studied significantly due to the frequentre-stenosis that occurs. The addition of stents to help prevent thisre-stenosis has merit and is gaining favor quickly, but does not stopre-stenosis and adds significantly to the treatment costs. In fact,significant development has occurred that deliver drug/agents/therapy tostents, again to prevent re-stenosis. The use of drugs to help preventre-stenosis shows great value. Stephen R. Bailey reports upon thesignificant development and reasons for such development in his articleentitled Local Drug Delivery: Current Applications, published inProgress in Cardiovascular Diseases, Vol. 40, No. 2 (September/October),1997: pp183-204. In fact, this is merely one several publicationsregarding the developments and research in this regard.

[0031] The drug or therapeutic agent delivery system of the instantinvention similarly to the aforementioned and novel dilatation system ofthis patent uses a very ‘manufacturing friendly’ process that will allowsimple fabrication on a production basis. Further and like theaforementioned dilatation system, this drug or agent delivery systemyields characteristics that allow for high safety and efficacy to thepatient while minimizing the efforts and time of the clinician.

[0032] The five objectives first described in the BACKGROUND OF THEINVENTION are important to a successful invention in today's complicatedmedical device industry and health care arena and bear repeating. Theyare reducing cost and complexity, using a procedure that the healthcareprofessional is familiar with and maximizing/optimizing safety andefficacy. The preferred embodiments of the instant invention address allfive of these objectives where the background art does not.

[0033] Dilation balloons are also commonly used to deploy stents orstent-grafts. Even farther, many stents or stent-grafts are configuredwith a multi-stranded, braided, sleeve or tube. One of the descriptionsof the present invention is similar to that of the braided sleeve.Hence, the present device can be used such that the stent or stent-graftcan be mounted on the inner/outer system described below and when putinto compression; the stent or stent-graft expands radially just as itdoes when it is mounted on a dilatation/deployment balloon).Alternatively, when the tubular braid dilatation system is used, thesystem could be modified so that the tubular braid is ‘detachable’ fromthe elongate shaft of the catheter or wire. In this case, it could beleft in place as a stent or stent-graft. The ‘detachable’ tubular braidcould be put into compression so that it expands. This may beaccomplished by having reinforcements on both sides of the tubular braidthat can be moved inward relative to one another to cause thecompressive force on the tubular braid. Once the forces are withdrawn,the tubular braid would remain in place in the vessel. Additionaldilatation from a balloon could be added now to ‘set’ the stent orstent-graft in place. Often, a stent or stent-graft only needs a ‘nudge’to start its expansion both in the case of self-expanding and balloonexpanding endoprostheses.

[0034] For these reasons, it is desirable to provide improved devicesthat may circumvent some of the problems associated with previoustechniques. This improved medical device provide a new configurationthat will eliminate some of those problems and methods for their use,which facilitate removal of vascular and other vessel obstructions,narrowing, constrictures, disease prevention, etc. in the operating roomor interventional suite.

SUMMARY OF THE INVENTION

[0035] In a first embodiment of the present invention provides animproved device (guide wire or catheter) of the type having an elongateflexible shaft with a proximal end and a distal end. The improvementcomprises configuring at least a distal portion of the flexible shaft sothat it can assume a shape(s) along its shaft (proximally, mid-sectionor distally) that will act as a dilator. This guide wire or catheter canbe moved along the lumen (artery, vein, intestine, stent, graft, orother hollow vessel or organ, etc.) and to the obstruction area (clot,plaque, or other obstruction). Once it is in the vicinity of theobstruction/constriction/narrowing, the user (physician/technician) caneasily actuate the dilation mechanism(s) so that it is enlarged beyondits original size/diameter and dilate the narrowed passageway. Further,a similar mechanism can be deployed distal to the obstruction so thatwhen the dilatation is occurring and fragments are dislodged during thetherapy, the distal mechanism can trap them from moving downstream.These emboli can be trapped and then obliterated or removed at somelater time.

[0036] A second embodiment of the instant invention, concerned withdelivery or a drug/agent/solvent to the vessel wall, is directed to atubular device, which has proximal and distal ends, constructed ofmonofilament or multifilament braids for use in the vascular system ofthe body. The braid, in a collapsed configuration, is elongated andwould fit over the deflated balloon of an angioplasty catheter in arelaxed manner. Although it may be essentially the same length as theangioplasty balloon (or other dilatation device), it would likely extendproximal to and distal to the balloon on the shaft of the catheter,being of greater length than the balloon. It may extend to the distaltip of the catheter and may be affixed to the catheter shaft at or nearthe tip, either permanently or releasably. It may also be affixed to thecatheter shaft proximally. It may have an attachment for engagement by aguide wire at its distal end or may be affixed to a wire or threadproximally. As will become apparent subsequently, a means for deployingthe braid device and un-deploying, or contracting, the device other thanthe balloon may be necessary.

[0037] In a preferred version of this embodiment, the braids are made ofa material, which has physical properties, which allow absorption offluids or drugs into the braid material in the relaxed or non-expandedconfiguration. This would be performed outside the body before insertionof the device. After insertion and when the dilatation device isdistended/expanded, the braid would expand with the device or as part ofthe device, be placed into a stretching tension and be compressedagainst the vessel wall. These two forces, stretching and compression,will cause the fluid, drug, solvent or other therapy residing within theabsorbent material of the braid to be displaced from the braid. Thisagent would the diffuse into the wall, in the case of the passivediffusion configuration. In the case of the active transport system,electrical charges would be utilized to either draw the agent into thewall or to pump the agent into the wall. Similarly, the agent could belocated between the dilatation mechanism and the outer braid or othermaterial coating the dilatation mechanism.

[0038] Alternatively, the braid may be constructed of tiny tubularfilaments, which may not have absorbent properties. However, becausethese filaments are tubular in nature, fluids containing drugs or othermaterials may be injected into them and delivered through them to thevessel wall. It is obvious that a means of injecting fluid into thefilaments, such as another lumen in the catheter carrying the device,may be necessary. In addition, the exit site of the tubular filamentscould take the form of small holes, porous material, slits, or justweakened areas of the filaments, just to name a few configurations. Thetubular design of the filaments of the braid would also add strength tothe device so that the outward radial forces needed for scaffoldingpurposes, described below, would be enhanced.

[0039] The braid may have other physical properties other thanabsorbency. The braid may possess enough rigidity to remain expandedafter the initial balloon distention, providing scaffolding to prevent,or significantly lessen, elastic recoil of the dilated vessel. The braidis multi-stranded and may be either mono or multifilament braid.

[0040] Additionally, the aforementioned tubular braided mechanism iseasily adapted for use at the exit site for a long term or indwellingcatheter or other tube. This exit site is problematic for a variety ofreasons; the most important of which is that it is a site when infectioncan occur. By using the tubular braid with the aforementioned diseaseinhibiting characteristics, the problems of this ‘exit site’ are greatlyreduced. It is a simple matter to manufacture the yarns/strands of thetubular braid using bio-resorbable materials well known to the medicaldevice industry such as, but not limited to de-hydrated collagenstrands. These strands readily absorb solvents/solutions andconcurrently could be designed to be reabsorbed by the body in apredetermined period of time.

[0041] While the device is augmented with several novel features toreduce disease and facilitate the angioplasty procedure, i.e., localdrug delivery, scaffolding, ridges causing micro-fractures, flow throughthe porous braid, and single catheter insertion, any one of thesefeatures may be used alone or in combination with any of the otherfeatures to inhibit disease and facilitate the angioplasty procedure.

[0042] As well, while the discussions have addressed the uses of thedevice within the vascular system, the device may be utilized in theform described, or in a modified form, within other passageways in thebody for local delivery of drugs, radiation, and other materials,scaffolding, hemostasis, disease treatment or prevention as well asother uses.

BRIEF DESCRIPTION OF THE DRAWINGS

[0043]FIG. 1-A is an illustration of a standard angioplasty catheter 1with a standard angioplasty balloon 4. In this illustration, theangioplasty balloon 4 is shown un-inflated as shown by the wrinkles 5 onthe un-inflated balloon 4 located near the distal end 3 of the device.This drawing is not exemplary of any preferred embodiment of the instantinvention, but rather serves as a platform for additional FIGS. 1-Bthrough 4. It is important to note that this drawing is only arepresentation of all angioplasty catheters and is not intended to bespecific. In this figure as well as all other figures where anangioplasty balloon 4 is represented, specific design parameters havenot been added such as the Y-Port adapter/valve that would usually be onan angioplasty balloon catheter. Such a Y-Port is usually used forfeeding a guide wire through the axial port and subsequentinflation/deflation of the balloon through the Y port. Said Y-Port islocated on the proximal end 2 of the device 1.

[0044]FIG. 1-B is an illustration of angioplasty balloon catheter of thepresent invention where a material 7 has been placed over the balloon 4to trap drugs or other agents or therapy during said angioplasty. Thedrawing illustrates braid 7 covering the balloon 4, however the instantinvention describes other materials other than braid. Further, theangioplasty balloon 4 is completely covered in the drawing with thematerial. Complete coverage is not mandatory for the instant invention.

[0045]FIG. 2 is an illustration of one preferred embodiment of theinstant invention where an angioplasty balloon 4 and another mechanicaldilator or deployment mechanism 9 is located on the same catheter/device8. In this figure, a stent 10 is also located on the proximal mechanicaldilator/deployment mechanism 9.

[0046]FIG. 3 is a schematic illustration of an embodiment of the instantinvention whereby the combination catheter of FIG. 2 is located in anarrowed vessel of the body.

[0047]FIG. 4 is a schematic illustration of an embodiment of the instantinvention whereby that by moving an inner wire or mandril in thedirection of the arrow, the distal aspect of the guide wire enlarges sothat it may engage the distal aspect of the device to expand themechanism there.

[0048] These illustrations show only some potential configurations ofthe present invention. Other parametric changes of the present inventioncan occur such as location of the described elements on the distalportion of the device as well as the actual type of mechanism(s) used.The location of these mechanisms may vary from the proximal to thedistal end although all figures illustrate a distal location. Further,specific design parameters that are not pertinent to the instantinvention are not delineated in the figures such as, but not limited toguide wires, valves, syringes, proximal deployment means, etc.

DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0049] The present invention is used for intervention into the tubularchannels (arteries, veins, biliary tract, urological tract,gastrointestinal tract, stents, grafts, sinuses, nasopharynx, heart,ears, etc.) or hollow cavities (stomach, gall bladder, urinary bladder,peritoneum, etc.) of the body. Further, it may be used in iatragenicallycreated passageways. It is particularly convenient to use in anenvironment of an operating room, surgical suite, interventional suite,Emergency Room, patient's bedside, etc. One preferred embodiment of thisdevice is that the elongate, flexible shaft is inserted into the tubularchannel or hollow cavity of the body usually through pecutaneous accessor via a surgical incision. In the case of lumens that enter and exitthe body naturally, the device may enter through one of those entry orexit paths (i.e. rectal opening, mouth, ear, etc.). Once the device isin the preferred location (that being where the narrowing or obstructionis located), the expandable dilation mechanism(s) is deployed (usuallyactuated by the physician outside the body) so that the configuration(s)on the device opens/deploys. As the dilating mechanism is expanded, itpushes outward with a radial force that dilates or compresses thetissue. In the case of blood vessels, this is often referred to PTA(Percutaneous Transluminal Angioplasty).

[0050] The deployment mechanism(s) on the system can be configured sothat it is ‘detachable’ so that when dilation has occurred, themechanism(s) (or part of it) can be left in place for scaffolding of thepassageway. This scaffolding is often referred to as an endoprosthesis,stent or stent-graft. Even further, a stent or stent-graft (or otherscaffolding prosthesis) can be mounted onto the mechanism(s) and thenleft in place post deployment/dilation. The dilator mechanism(s)described herein are usually inserted into the patient in an un-deployed(smaller) fashion. It may arrive in the package in a deployed orun-deployed state.

[0051] Referring to FIG. 1-A, illustrated is a standard dilatationcatheter 1. This particular catheter 1 is a balloon catheter as isillustrated by the uninflated balloon 4 located near the distal end 3 ofthe catheter 1. The proximal end 2 of the catheter is generic and doesnot specify other parameters usually seen with a balloon dilatationcatheter. For instance, not illustrated is the usual Y-Port that islocated near the proximal end 2 of the catheter. The balloon 4 of thisfigure is shown uninflated or deflated in the illustration as isrepresented by the wrinkles 5 in the balloon 4. The wrinkles in the wallof the empty balloon indicated that likely an inelastic material is usedto make the balloon 4. However, the instant invention may use anelastic, relatively inelastic or inelastic material for the balloon.FIG. 1-A is an illustration of a nonspecific dilation device to serve asa basis for delineating the preferred embodiments of the instantinvention.

[0052] Turning now to FIG. 1-B, a dilation catheter 6 of the instantinvention is illustrated. In this embodiment, tubular braid 7 is mountednear the distal end 3 of the catheter 6. In this illustration, thetubular braid 7 is mounted over a dilation balloon 4. The dilatationballoon 4 is difficult to see in the drawing due to the braid 7 coveringit. However, the tubular braid 7 alone could be illustrated whereby noballoon 4 is required. In such a case (in contrast to inflating aballoon), the braid would likely be put into a compressive state toexpand the tubular braid 7 radially outward. In FIG. 1-B, the tubularbraid 7 may be made of an absorbent material so that a drug, agent orother therapy can become impregnated or absorbed into the individualyarns of the braid or within the interstitial spaces between the braidor in the space between the braid 7 and the balloon 5. Further, acoating (not shown) could be applied over or within the braid toaccomplish the same. When such an agent is used and the dilatationdevice 7 or 5 is radially expanded into the narrowed tissue, the agentcan be delivered ‘locally’ to the narrowed tissue. Additionally, theexterior material on the dilatation mechanism may have coarse orotherwise characteristics so that the material will have a tendency tobe greater or otherwise impregnated into the narrowed tissue. This mayhave several advantages. It may help disturb the organized matrix of thetissue that is narrowed. Further, it may help deliver the therapy deeperinto the narrowed tissue. Even further, it may help keep the agent inthe narrowed tissue during the dilation period. This may be particularlyuseful in a dynamic flow situation such as in the case of PTA whereblood flow may be present during dilatation.

[0053] Turning now to FIG. 2, another embodiment of the instantinvention is illustrated. In this drawing, an elongate device 8 with twoseparate dilators (4 and 9) is shown. The device 8 shows two dilationmechanisms located near the distal end 3 of the device. The most distaldilation mechanism illustrated in this figure is a dilatation balloon 4.Somewhat proximal to the balloon is a second dilatation mechanism 9. Theproximal dilatation mechanism 9 illustrated here is a tubular braidtype. Again, radial expansion outward of the dilatation mechanism 9 isusually accomplished by putting the tubular braid into a compressivestate. Further, mounted onto the proximal dilatation mechanism 9 is ascaffolding endoprosthesis 10 often referred to as a stent orstent-graft. It is noted that the stent and stent deployment is notillustrated here. One embodiment of the instant invention is that thedevice 8 will be inserted into a narrowed space, usually with the aid ofa guide wire (not shown) and when the distal dilatation mechanism 4 isradially expanded, the narrowed space is expanded. Once the space issomewhat enlarged, the device 8 is moved forward so that the proximaldilatation mechanism 9 and endoprosthesis 10 are oriented into the area.The proximal dilation mechanism 9 is then expanded radially so that theendoprosthesis 10 is deployed into the once narrowed area to help keepthe area propped open or otherwise scaffolded. It is important to notethat the dilation mechanisms 4 and 9 on device 8 can be interchangedwith respect to location along the device 8. Further, the device mayhave two balloon dilatation mechanisms or two other types of dilatationmechanisms. Further, the tubular braid 7 or 9 may be designed so that is‘detachable’ from the device 8 so that it may act as both the dilator 9and the endoprosthesis 10 or either.

[0054] Referring now to the dilation mechanism 9, a multi-stranded (monoor multi filament) tubular braid, also referred to as braided sleevingis illustrated. When the braid is put into compression, the braid ispulled together and it flares out to create a larger diameter.Alternatively, either the braid or the other mechanism (like the malecotmechanism described below) can have a permanent set put into in so thatit is normally open with the larger diameter. In this case, when it isput into tension (usually from some inner (or outer) core wire ormandril), it collapses down to the diameter of the shaft of the device8. Alternatively when these ‘normally open/deployed’ mechanisms could beconstrained to a smaller ‘unopened’ diameter with a slideable over tube.This braided sleeve/tubing described is similar to a common child's toyof years ago, known as Chinese Finger Cuffs. In this case, when thetubular braided sleeve is pushed together, the braided assembly enlargesradially. It can enlarge with significant outward radial force. Hence,this outward radial force can cause the dilation. Further, this braidedconfiguration can have a roughened surface that may be very useful inbreaking up the matrix of the stenosis. In other words, as mentionedabove in the prior art, the braid can act as a cutter as would the tinycutters on the balloon. Further, because the braid may be porous, drugsor other therapies can be dispensed during dilatation or other placement(in the case of an exit site catheter/device for example). Further, theinterstitial porosity allows other mechanisms to be passed through thewall of the braid for therapy.

[0055] Alternatively, too much abrasive action on the surface of thedilatation mechanism(s) may be deleterious to the patient as well. Inthe case of the braided configuration, some smoothener may be requiredso that just the appropriate amount of surface roughness is realized foreffective matrix disorganization/disruption. This surface covering couldbe total or partial covering of the device as required for theparticular application. Further, the realized rigidity of any of thetype of mechanism(s)s must be optimized for the particular application.Even further, this smoothener added to the tubular braid may aid areceptacle for holding the agent or as a porous membrane for the agentto pass through.

[0056] The expansile mechanism of the dilation system can be fabricatedfrom several materials and configurations. The strands (of the braid)can be made of any material that would be useful for a particularapplication (polymers like polyester, nylon, Mylar, etc.) or, metal(stainless steel, Nickel Titanium Alloy (Nitinol), platinum, etc.). Thesame is true for the malecot (not illustrated and described below).Certainly, the materials of the present invention are not constrained tothose materials listed. Additionally, the mechanism may be coated orencased in an elastomeric, inelastic or other covering. Further, themechanism may be fabricated of a material that will enlarge due todifferent forces than that of the braid mentioned previously. One othersuch force derived mechanism could be a material that swells/enlargeswhen put into a moist environment. Another such forced derived mechanismis one that swells/enlarges when put in a temperature differential. Yet,another may be one that occurs from an electrical, magnetic or othermechanical configuration/design/force. The dilation mechanisms could beradially expanded in their relaxed state or radially compressed in theirrelaxed state.

[0057] Another preferred embodiment of the present invention is theavailability of different porosities. This is critical. As the braid ismade up of filaments, the porosity can be varied. This can allow drugsto be passed through the wall (which is made up of individualfilaments). Equally important or maybe more important, when conventionaldilating balloons are used, the vessel is totally occluded for theperiod of therapy that dilation is occurring. As previously, mentioned,lavish perfusion balloons have been developed so that perfusion (bloodflow) can occur during dilation. As one expands the braid (or themalecot), as it expands to its fullest diameter, the porosity on theouter wall decreases and becomes ‘solid’ in nature. However, both endsof the expanding braided mechanism remain porous. Hence while thedilation is occurring, blood can flow through the dilating member.

[0058] Further, as mentioned briefly above, the filaments of the braid(or malecot) change orientation, as they are expanded/enlarged. Thischanged orientation may be helpful in breaking up the matrix of theunderlying disease. Further, the porosity of the braid (or malecot)changes during the dynamics of the enlarging process. This too may behelpful in that the filaments will ‘grab’ part of the intimal wall whileenlarging/expanding. Further, it will continue to grab the inner walland stress it or change it somehow so that re-stenosis is greatlydecreased.

[0059] As taught, possible configurations of the distal mechanism(s) arevaried. Illustrated is tubular braid 9 or 7 and balloon 4 mechanisms.Another such mechanism and a preferred embodiment of the presentinvention use a configuration known as a malecot (not illustrated). Thismalecot is a common configuration used in catheters for holding them inplace (in the case of feeding tubes in the intestines or stomach). It isusually a polymeric (but may also be metal) tube that has more than one,but usually two or more slits symmetrically opposed. When the distal tipof the malecot is put into compression (usually by pulling an inner wireor mandrel or tube), the sides of the polymer are pushed outward so asto create a larger diameter on the distal tip. This enlarged distalmalecot diameter is larger than the body/shaft of the device. In thecase of this malecot type mechanism, the surface of the malecot could beroughened or a separate membrane (attached or not) could be put over orunder the malecot so that it is roughened or strengthened or added foranother reason.

[0060] Turning now to FIG. 3-A, the device 8 of FIG. 2 is partiallyillustrated in a narrowed blood vessel 11. The narrowing of the bloodvessel 11 is indicated by the formation of plaque 12 attached to theintimal lining 13 of the vessel. The device 8 has been inserted into thebody and blood vessel 11 until the distal dilation mechanism 4 isoriented appropriately in the narrowed space. In this figure, thedilatation mechanism is a dilatation balloon 4. The device 8 and balloon4 are oriented to the correct location with the aid of imageintensification (x-ray, ultrasound, MRI, etc.). Once in the appropriatelocation, the dilation mechanism is deployed/dilated to expand thenarrowed vessel 11. This dilatation process is not illustrated. Oncecomplete the dilatation mechanism 4 is un-deployed and thecatheter/device 8 is advanced further into the vessel as illustrated inFIG. 3-B. The plaque 12 of FIG. 3-A has been compressed and the vesselis somewhat expanded so that the narrowing is decreased. This compressedplaque 15 has a tendency to recoil so often anendoprosthesis/stent/stent-graft 10 is desired to be placed into thedilated vessel 14 to help keep it propped open. Once the seconddilation/deployment mechanism 9 is oriented appropriately in the dilatedvessel 14, it is deployed. In FIG. 3-B the second dilation mechanismillustrated is a tubular braid 9 with a stent 10 mounted onto it. Oncedeployed, the stent 10 remains in place in the newly dilated vessel 14.It may be desired to pull the device 8 backward just enough so that thefirst dilatation mechanism, in this case a balloon 4, is oriented nearthe position of the newly implanted stent 10. In this case, the firstdilatation mechanism 4 can be dilated (inflated) a second time tofurther expand and/or embed the stent 10 into the dilated wall 16 of thevessel 14. In fact, this is often the case in normal practice for theinterventionalist, especially in the case where self-expanded stents areused.

[0061] The scaffold 10 and or the dilating mechanisms 9 or dilatingmechanism 4 is preferably coated with a medical grade substance havinglow thrombogenicity or other medicament that helps prevent deleteriouseffects that may accompany these procedures. Alternatively, the scaffold10 may be coated with any of a variety of fabrics/textiles that allowtissue growth into it, other stabilization or other preferredcharacteristic. Further, the scaffold 10 or dilating mechanisms 4 and 9may be impregnated with radioactivity, monoclonal anti-bodies or avariety of other medicaments that may inhibit re-stenosis or otherdeleterious effects that wish to be avoided. Further, the braid can becoated with an elastomer or plastically deformable material so that itmight go from a small size to a large size and the interstitial spacesare coated with some porous or non-porous material. One, but certainlynot the only way to accomplish this coating is to first dilate the braidto a larger diameter by placing an inner rod or mandril inside thetubular braid/braided sleeving. At this point, the assembly is coatedwith a liquid dispersion and allowed to dry/volatilize. Once dry, theinner rod is removed and the system can be put into tension and thediameter will decrease to the original small diameter. This process canbe accomplished by impregnating the tubular braid with a thermoplasticmaterial as well as thermoset.

[0062] Turning now to FIG. 4, an embodiment of the instant invention isillustrated where the dilation mechanism is a tubular braid/braidedsleeving 9. In the case of a dilator only, the distal end 17 of tubularbraid 9 is bonded to the distal end 17 of the inner wire or tube 20. Theproximal end 18 of the tubular braid 9 is bonded to the outer tube 19which will likely end at 18. In one preferred embodiment, moving theinner mandril or tube 20 relative to the outer tube 19 to expand thedilator 9 actuates the dilator. In another preferred embodiment, asecond outer tube (not shown) can be slid over the dilation mechanism tokeep it in the smaller diameter and then removed to allow it to expand.This might be the deployment mechanism used when the normal relaxedcondition of the dilator is in the expanded/larger condition.

[0063] Turning now to FIG. 4-B, the inner mandril or tube 20 has indeedbeen moved relative to the outer tube 19 as indicated by the arrow 21.The dilating mechanism is thus expanded as indicated by 22. Themechanism illustrated in FIG. 4 is a tubular braid mechanism, however,the malecot design could also be used.

[0064] Drawings of the device of the present invention are included inthe appendix. An exemplary device has the following characteristics:

[0065] Working Length

[0066] 10-500 cm

[0067] Working Diameter

[0068] The inner wire/mandril of the present invention has an outerdiameter that ranges from 0.006 to 0.150 inches, usually in the range of0.008 to 0.035 inches but can extend to smaller and larger sizes astechnology and procedures require. The outer tube/shaft of the instantinvention has an inner diameter that will accept the inner wire/mandril,an outer diameter in the range of 0.020 top 0.400 inches usually in therange of 0.030 to 0.200 inches but can extend to smaller and largersizes as technology and procedures require. The dilation mechanism ofthe present invention would be small in its un-deployed state (similarto that of the wire or tube mentioned above, depending on theconfiguration), but would be expandable to diameters of 0.010 to 0.500inches, but usually in the range of 0.030 to 0.400 inches, but canextend to smaller and larger sizes as technology and procedures requireor even larger. The dilatation mechanism will usually have twodiameters, a smaller/undeployed diameter which would be in the range of0.010 to 0.100 inches or even larger. The larger/deployed state of themechanism may extend from 0.050 to 2.00″ inches or even larger dependingupon the vessel being dilated.

[0069] Physical Configuration

[0070] The device of the present invention may have conventionallubricious coatings to enhance introduction into the target body lumen,e.g. hyaluronic or other equivalent coatings. Further, the technicianmay apply a lubricious coating just prior to surgery. As an advantage ofthe present invention, the device will be less difficult to feed it tothe desired location in the body due to its decreased size. Anotheradvantage of the present invention would be the ease with whichobstructions can be snared for removal or obliteration. This decreaseddifficulty will decrease cost due to time in the Operating Room(Operating Rooms costs are estimated in excess of $90 dollars per minutein the U.S.) Additionally, there will be realized a decrease indifficulty for perfusion during treatment that will aid in patientcare/recovery and the potential in deleterious effects due to the totalocclusion during conventional treatment.

[0071] An exemplary device having dilating mechanism(s) located on itsdistal tip is illustrated in FIGS. 1-4. The mechanism(s) may be at thetip or somewhere else in the distal portion of the device or even in themiddle of the device. Additionally, this mechanism(s) may be any of anumber of mechanisms that will help aid in dilating the tissue. In allFIGS. 1-3, the dilation mechanism/system is illustrated in itsun-deployed condition. In FIG. 4-B, it is in its deployed condition.

[0072] As previously mentioned, emboli can become loosened during manyof these therapies and these emboli can have deleterious affects‘downstream’. This occurrence would appear to be increased with a LISapproach due to the fact that in an open procedure, the site of revisionis in direct view so that this particulate should be more easilydetected and removed. Conversely, in a LIS procedure the physician isdependent upon image intensification and his or her actual skill to notallow emboli from being dislodged and causing ‘downstream’, distalproblems. The instant invention may likely be used with a distalprotection system as described.

[0073] It is an object of the invention to provide a catheter/device fordeploying an endoprosthesis/stent/stent-graft.

[0074] It is yet a further object of the invention to provide anendoprosthesis deployment device or guide wire with the added ability todilate the narrowed passageway using the same device.

[0075] It is still a further object of the invention to provide a systemfor dilating a narrowed passageway.

[0076] It is another object of the present invention to allow thedilating mechanism to have an irregular surface for disturbing thematrix of the narrowed intima of the tissue to aid in the therapy.

[0077] It is another object of the present invention to allow perfusionthrough the dilating mechanism.

[0078] It is another object of the present invention to allow deliveryof drugs, energy, mechanisms, etc. through or into the walls of thedilating mechanism to aid with such therapies.

[0079] It is still a further object of the invention to provide a systemfor allowing the delivery of a drug or other therapeutic agent to thedilatation site at the time of dilatation and this iteration isdescribed below. The preferred version of this embodiment relies on apassive system of drug delivery, in concert with the objectives to keepthe device simple, inexpensive, and easy to operate.

[0080] The passive system for delivery of the drug or other agent willrely primarily on diffusion of the concentrated drug into the vesselwall. An active system may use a process referred to as iontophoresis,which because of a differential in electric charges essentially pumpsthe drug into the vessel wall and perivascular soft tissues. Oneembodiment employs a novel method of iontophoresis, which uses thenormal negative resting potential of the heart and the normaldepolarization/repolarization cycle to draw the drug into the vesselwall and perivascular tissues.

[0081] The device is simply soaked in a container of fluid whichcontains a drug or other material, absorbing a quantity of the fluiddetermined by the size and composition of the braid and, to a lesserextent, the type of fluid. The fluid may contain any drug or othermaterial approved for use within the body by the Food and DrugAdministration. The device, including the angioplasty balloon, isinserted into the blood vessel, the angioplasty balloon positionedappropriately, and the balloon inflated in a standard manner. Thedistention of the angioplasty balloon stretches and compresses the braidso that the braid releases the fluid containing the drug or othermaterial adjacent to the arterial wall, where it is absorbed into thearterial wall by passive diffusion.

[0082] Alternatively, an active transport mechanism may be provided tobetter facilitate the transfer of the drug or material into the vesselwall. One active transport system is Iontophoresis, which uses adifferential in electrical charges to either pull the drug or materialinto the vessel wall or to pump it from the inner surface of the vesselinto the vessel wall. The configuration of the electrodes within thedevice, the catheter, or the body may take any one of several forms.There may be an external electrode on the patient's body and an internalelectrode within the braid device or the angioplasty catheter. There maybe two internal electrodes, one within the braid device and one withinthe angioplasty catheter. The electrodes may be placed elsewhere, i.e.,on the guiding catheter or on the guide wire. In the case of a stent,the stent may act as an electrode and the second electrode may beincorporated into any one of the locations described. One configurationinvolves a single electrode in the braid device or any of the otherlocations, and uses the normal negative resting potential of the heartto draw the drug or material into the vessel wall. In fact, there may beany combination of the above configurations.

[0083] It is likely that, in the case of intracoronary iontophoreticallyenhanced drug delivery; the device will be synchronized with theelectrocardiogram to deliver tiny pulses of electrical charge. Thesepulses may be delivered in the depolarization phase, the repolarizationphase, the resting phase, or the refractory phase or period. A separateprogrammable device would control the delivery time, amplitude, voltage,current, etc., and the synchronization with the electrocardiogram.

[0084] The operator would initiate the iontophoretic components at theonset of balloon inflation, typically, although initiation after orduring balloon inflation is also possible. If the braid device remainsexpanded after the initial balloon dilatation, the iontophoreticcomponents may be activated continuously even after the angioplastyballoon is deflated. This will allow the process to continue whileallowing for blood flow through the site of the lesion because of theporous nature of the braid device. In the case of the passive diffusionconfiguration, the braid device will maintain contact with the vesselwall continuously, allowing more material to diffuse into the vesselwall.

[0085] The braid device will also act as scaffolding to prevent elasticrecoil during the balloon deflations. This is secondary to the radialforces caused by the braid device being shortened during the ballooninflation. Therefore, the braid device would diminish elastic recoil byacting as scaffolding and because of the micro-fractures caused in theplaque matrix. These micro-fractures would disrupt the structure of theplaque it would not tend to reassume its pre-dilated shape.

[0086] Moreover, the present invention may be utilized with a stent toprovide pharmacological and mechanical means of combating re-stenosis. Aself-expandable or balloon expandable stent may be used, and the stentmay or may not be designed and packaged for use with the device.Additionally, the device may have the properties of a scaffold or stentand actually act as means to mechanically counteract the forces ofelastic recoil without the presence of a separate stent.

[0087] While the discussion centers on braid design, it is the expressintent that this patent should cover any material whether braided,woven, molded, pressed, sliced, compressed, expanded, or any othermaterial which has the capacity to absorb a drug or other substancecontaining a physiologically active ingredient, and release that drug ormaterial when compressed. For example, the device may be constructed ofa sponge material or foam material, which would absorb the drug or othersubstance, and then release that drug or material when compressed by theexpanding balloon. In fact, some other force other than compression mayaccomplish the release of the absorbed drug or material.

[0088] As mentioned above, the texture of the braid over the angioplastyballoon will create tiny micro-fractures within the plaque matrix whichwill reduce damage to the vessel wall, diminish the incidence ofdissections, diminish the elastic recoil of the wall, and allow for moreuniform compressibility of the plaque. All of these factors have beenimplicated in the re-stenosis process. This action, even without thedrug delivery features, may diminish re-stenosis. However, by creatingthe tiny micro-fractures within the plaque, the drug is able to bedelivered in a better proximity to the vessel wall than without thisproperty. The braid will likely become slightly and temporarily imbeddedwithin the micro-fractures of the plaque, creating a desirable situationwhich enhances delivery of the drug or material into the plaque andvessel wall because of proximity, and, concomitantly, decreases theamount of drug or material which is washed away by the flowing blood.

[0089] The operator would inflate the angioplasty balloon a single ormultiple times, while simultaneously delivering the drugs, fracturingthe plaque, and preserving the distention of the lesion with the braiddevice. As one can see from the foregoing description of the preferredembodiment, the drug delivery and other actions are accomplishedessentially during the angioplasty procedure and there is no need for asecond catheter insertion to deliver the drug or other material or toeffect the other actions of the device with the embodiment described.Obviating the need to reinsert another catheter to accomplish thisaction saves a significant amount of time, expense, and potential riskto the patient. However, in another embodiment, the drug delivery andother actions could be performed with a device separate from theangioplasty catheter or on another balloon on or separate from theinitial angioplasty catheter. In still another embodiment, the actionscould be performed in concert with a stent deployment. The operation ofthese other embodiments will not be described, but are similar to theoperation of the preferred embodiment.

[0090] The un-deployment or contraction of the braid device from thevessel wall deserves special attention since the braid device will notcontract to its original state when the balloon is deflated, at least inthe preferred embodiment in which it acts as a scaffold while theballoon is deflated. The braid device may be returned to its originallow profile shape over the deflated angioplasty balloon by one ofseveral means, which by mention, are incorporated into the presentinvention.

[0091] The distal end of the braid device may be constructed so that itengages a guide wire, so that by advancing the guide wire, withdrawingthe catheter, or a combination of these motions, the braid deviceelongates and returns to its original undeployed shape and state. Theguide wire may contain an expanded portion that will engage the braiddevice or there may be a portion of the guide wire, which expandsbecause of traction on an inner core of the guide wire. This expandableportion of the guide wire may be constructed of a flexible braid orother material.

[0092] The braid device may be collapsed or contracted by holding thecatheter in place and pulling on a wire or thread attached to theproximal portion of the braid device. Alternatively, if the braid devicewere affixed to the catheter shaft proximal to the balloon, simplywithdrawing the catheter would cause the braid device to disengage thevessel wall and elongate.

[0093] Still another means of collapsing the braid device after use maybe to use a shaped memory alloy within the braid. The shaped memoryalloy would be formed so that it would cause the braid to seek acollapsed, elongated, tubular shape after expansion when the distendingballoon is deflated. This alloy may be used as a filament within thebraid, but also may be disposed as longitudinal lay-ins between thebraided filaments. Horizontal lay-ins may also be utilized to aid inreturning the braid device to its original undeployed state. Acombination of any of the collapsing means may be used, as well.

[0094] Further, it is yet another object of the instant invention toprovide a novel prosthesis/tissue interface that prevents, treats orinhibits disease during implantation such as long term indwellingcatheters which may be used to inhibit or treat re-stenosis or disease.This is a device to be used on any long term indwelling catheter in thelumens or cavities of the body at the site the catheter exits thepatients skin. There is a need to stabilize the catheter and prevent itswithdrawal and to promote healing of the skin around the exit site toprevent infection, irritation, need for daily care, weeping, inabilityto shower, etc. The exit site device of the instant invention addressesand solves these problems with a unique expandable braid of collagenyarns which can be attached to the synthetic material of the catheterand will allow the ingrowth of skin into the device. In other words, theskin will not grow into or attach itself to the foreign cathetermaterial directly. This new exit site device in constructed so it can beaffixed to the catheter and the skin will then grow into the devicecreating a seal between the skin and the catheter. This exit site deviceis usually constructed of a braid, similar to the drug delivery deviceabove, and is meant to be placed over or on the catheter just beneaththe skin. The purpose of this device is to encourage the skin to healover the catheter and produce a tight seal preventing the ingress ofbacteria, fungus, and contaminants into the catheter tract. Theindwelling catheter creates a crevice in the tissues and the epidermistends to grow down this tract, frequently carrying bacteria with them.This results in infection in the catheter tract. This device wouldcreate a bond between the skin and the catheter utilizing braidedcross-linked collagen attached to the outer portion of the catheter in atubular matter. The collagen lattice will provide an optimal frameworkfor the ingrowth of normal tissues, which would be affixed to amembrane, such as silicone, which in turn, would be affixed to thecatheter. If the device were constructed from a braid, foreshorteningthe braid would cause diametric expansion of portions of the braideddevice, causing it to initially assume a football like shape andsubsequently a plate like shape, depending on the forces applied. Thiswould cause an anchor like effect within the tissues and preventmovement of the catheter. Alternatively, the device may be constructedof material other than collagen and may not necessarily be of braidedconstruction. A spiral or helical configuration is possible and thispatent is to cover any expansile configuration, i.e., the devicemaintains a low profile shape upon insertion but is changed to adiametrically expanded shape after insertion for anchoring purposes. Thepreferred embodiment, being a braided collagen device, may have only oneend of its tubular configuration attached to the catheter. Forcing thenon-attached end of the tubular braid toward the attached end will causethe braid to deform into the shapes above. Alternatively, the device maybe in a football or plate-like shape initially, and tension may berequired to cause it to assume a tubular shape for insertion, forexample.

[0095] The features of the invention believed to be novel are set forthwithin the description of this disclosure. However, the inventionthemselves, both as to organization and method of operation, togetherwith further objects and advantages thereof may best be understood byreference to the following description taken in conjunction with theaccompanying drawings.

[0096] The Tubular Braid or Braided Sleeve Element

[0097] The braided sleeve or tubular braid apparatus described hereininclude an expandable tubular braid. In the case of the dilatingapparatus, an inner mandril or wire may be used o contact the tubularbraid. The elongate mandril extends from the proximal end of the deviceto the distal end of the tubular braid. The distal end of the tubularbraid is bonded/attached to the distal end of the inner elongatemandril. The mandril may extend beyond the tubular braid. The proximalend of the tubular braid is bonded to the distal end of an elongatetube. In the case of the drug delivery element, the tubular braid may ormay not be attached to the substrate catheter. In this case, the tubularbraid will be used as a means to deliver the drug or other agent to thelesion or to break up the matrix of plaque in the lesion.

[0098] The braid may be open, but may be laminated or covered with acoating of elastic, generally inelastic, plastic or plasticallydeformable material, such as silicone rubber, latex, polyethylene,thermoplastic elastomers (such as C-Flex, commercially available fromConsolidated Polymer Technology), polyurethane and the like. Further,the inventors of the instant invention have disclosed a method ofcoating the interstitial pores of the tubular braid without adding tothe overall wall thickness of the tubular braid. This manufacturinginvention is disclosed in pending provisional submission Ser. No.60/121,640. The assembly of tube, mandril and braid is introducedpercutaneously in its radially compressed state. In this state, theoutside diameter of the braid is close to the outside diameter of theelongate tube. This diameter is in the range of 10 to 50 mils, andusually 25 to 40 mils (i.e. thousandth of an inch). After insertion,moving the mandril proximally with respect to the tube expands thetubular braid.

[0099] The tubular braid is preferably formed as a mesh of individualnon-elastic filaments (called “yarns” in the braiding industry).Nevertheless, it can have some elastic filaments interwoven to createcertain characteristics. The non-elastic yams can be materials such aspolyester, PET, polypropylene, polyamide fiber (Kevlar, DuPont),composite filament wound polymer, extruded polymer tubing (such as NylonII or Ultem, commercially available from General Electric), stainlesssteel, Nickel Titanium (Nitinol), or the like so that axial shorteningcauses radial expansion of the braid. These materials have sufficientstrength so that the engaging element will retain its expanded conditionin the lumen of the body while removing the obstruction therefrom. Inthe case where the tubular braid is used as an absorbent material fordrug or other agent delivery, the individual filaments may be absorbentin nature or as stated earlier, the drug or other agent may be merelytrapped in between the tubular braid and the underlying dilating member.

[0100] The braid may be of conventional construction, comprising roundfilaments, flat or ribbon filaments, square filaments, or the like.Non-round filaments may be advantageous to decrease the axial forcerequired for expansion to create a preferred surface area configurationor to decrease the wall thickness of the tubular braid. The filamentwidth or diameter will typically be from about 0.5 to 25 mils, usuallybeing from about 5 to 10 mils. Suitable braids are commerciallyavailable from a variety of commercial suppliers.

[0101] The tubular braids are typically formed by a “Maypole” dance ofyarn carriers. The braid consists of two systems of yams alternatelypassing over and under each other causing a zigzag pattern on thesurface. One system of yarns moves helically clockwise with respect tothe fabric axis while the other moves helically counter-clockwise. Theresulting fabric is a tubular braid. Common applications of tubularbraids are lacings, electrical cable covers (i.e. insulation andshielding), “Chinese hand-cuffs” and reinforcements for composites. Toform a balanced, torque-free fabric (tubular braid), the structure mustcontain the same number of yarns in each helical direction. The tubularbraid may also be pressed flat so as to form a double thickness fabricstrip. The braid weave used in the tubular braid of the presentinvention will preferably be of the construction known as “twodimensional, tubular, diamond braid” that has a 1/1 intersection patternof the yarns which is referred to as the “intersection repeat”.Alternatively, a Regular braid with a 2/2 intersection repeat and aHercules braid with an intersection repeat of 3/3 may be used. In allinstances, the helix angle (that being the angle between the axis of thetubular braid and the yarn) will increase as the braid is expanded. Evenfurther, Longitudinal Lay-Ins can be added within the braid yarns andparallel to the axis to aid with stability, improve tensile andcompressive properties and modulus of the fabric. When theselongitudinal “Lay-In” yams are elastic in nature, the tubular braid isknown as an elastic braid. When the longitudinal yams are stiff, thefabric is called a rigid braid. Biaxially braided fabrics such as thoseof the present invention are not dimensionally stable. This is why thebraid can be placed into an expanded state from a relaxed state (in thecase of putting it into the compressive mode). Alternatively this couldbe a decreased/reduced (braid diameter decreases) state when put intotension from the relaxed state. When put into tension (or compressionfor that matter) the braid eventually reaches a state wherein thediameter will decrease no more. This is called the “Jammed State”. On astress strain curve, this corresponds to increase modulus. Much of theengineering analysis concerning braids is calculated using the “JammedState” of the structure/braid. These calculations help one skilled inthe art to design a braid with particular desired characteristics.Further, material characteristics are tensile strength, stiffness andYoung's modulus. In most instances, varying the material characteristicswill vary the force with which the expanded condition of the tubular canexert radially. Even further, the friction between the individual yamshas an effect on the force required to compress and un-compress thetubular braid. For the present invention, friction should be relativelylow for a chosen yam so that the user will have little trouble deployingthe engaging element. This is particularly important when the engagingelement is located a significant distance from the user. Such is thecase when the percutaneous entry is the groin (Femoral Artery forvascular interventions) and the point of engaging the engaging elementis some distance away (i.e. the Carotid Artery in the neck). Similarly,this is true for long distances that are not vascular or percutaneousapplications.

[0102] Therefore, in summary, the use of the device is relatively simpleand adds little time to the procedure and potentially a significantbenefit to the patient. The drug or other material is delivered at thesame time and with the same catheter as the angioplasty and the deviceis removed with the angioplasty balloon, in the preferred embodiment. Inaddition, other actions occur at this time (scaffolding andmicro-fractures) which also contributes significantly to inhibit there-stenosis process.

[0103] While preferred embodiments of the present invention have beendescribed in detail, it is apparent that modifications or adaptations ofthe embodiments will occur to those skilled in the art. It is to beexpressly understood, however, that such modifications and adaptationsare within the scope of the present invention.

What is claimed is:
 1. A therapy delivering device for use in apassageway of the body comprising: a catheter having a distal end and aproximal end, said catheter having a radial tubular element whichinhibits or treats disease, said tubular element comprised of a tubularbraid or braided sleeving configuration
 2. The device of claim 1 inwhich the tubular element has absorbent characteristics to deliver saidabsorbed therapy to the passageway.
 3. The device of claim 1 in whichthe tubular element is composed of hollow individual tubular fiberswhich are used to deliver therapy to the passageway.
 4. The device ofclaim 1 which is placed or fitted over an angioplasty balloon.
 5. Thedevice of claim 4 where therapy is delivered through the tubular braid,where said therapy is an agent that has been placed between the tubularbraid and an underlying radially expanding element.
 6. A device for usein a passageway of the body comprised of tubular mesh braid element,that enlarges said passageway and delivers an endoprosthetic scaffoldusing two enlarging mechanisms on the same device, one mechanism usedfor enlarging, and one mechanism used for deployment.
 7. The device ofclaim 6 that includes a dilatation balloon as one enlargement mechanism.8. The device of claim 1 which uses an active transport system todeliver therapy into the passageway.
 9. The device of claim 8 in whichthe active transport system is iontophoresis.
 10. The device of claim 1which acts as a temporary or permanent scaffold in the passageway. 11.The device of claim 1 which creates micro-fractures or other separationsin the inner wall of the passageway.
 12. The device of claim 1 in whichthe therapy delivered is a drug.
 13. The device of claim 1 in which thematerial delivered is genetic material.
 14. The device of claim 1 inwhich the material delivered is radiation.
 15. The device of claim 1which is used with a dilating inflatable balloon.
 16. A device for usein the lumens of the body to inhibit re-stenosis comprising a materialwhich will absorb a drug or other substance for transport to the site ofdeposition.
 17. The device of claim 16 which uses a dilating, inflatableballoon to expand and compress the material causing release of thetherapy into the passageway.
 18. A device used at the body exit site ofindwelling catheters comprising an tubular braid element used to securethe catheter at the exit site of the body.
 19. The device of claim 18which is comprised of a bioresorbable material.
 20. The device of claim19 where the bioresorbable material is collagen.
 21. The device of claim18 where the constituent materials used in the braid element contains atherapeutic agent, where said therapeutic agent is from a family oftherapies including drugs, radiation, genetic agents or autologousmatter.
 22. A method whereby a therapy delivering device is used in apassageway of the body to inhibit or treat disease, where said device isat least partially comprised of tubular braid.
 23. A method of claim 22where the tubular mesh braid at least partially covers an angioplastyballoon.
 24. A method of claim 22 where tubular mesh remains in place inthe passageway as an endoprosthesis.
 25. A method of claim 22 where thetubular braid is mounted on an indwelling catheter.